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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Posterior Cervical Screw System
510(k) Number K254260
Device Name The VEGA Cervical Screw System
Applicant
GS Medical Co., Ltd.
90, Osongsaengmyeong 4-Ro, Osong-Eup
Heungdeok-Gu
Cheongju,  KR 28161
Applicant Contact Sun Ju Choi
Correspondent
RQMIS, Inc.
110 Haverhill Rd.
Suite 524
Amesbury,  MA  01913
Correspondent Contact Barry Sands
Regulation Number888.3075
Classification Product Code
NKG  
Date Received12/29/2025
Decision Date 09/17/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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